Reader, Be Wary: Sponsors Keep Most 'Complete Response' Letter Content Under Wraps, FDA Says
Agency analysis provides rare portrait of 'complete response' letters while adding to the case for increased transparency.
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US FDA's complete response letters dropped from 41 in 2016 to 30 in 2017; quality issues as share of total letters continued to climb.
But Amgen is in good company when it comes to companies that choose not to disclose the contents of complete response letters, data from the Pink Sheet's FDA Performance Tracker show. Merck especially holds such information close.
Some of the most valuable lessons learned out of Pharmaceutical Approvals Monthly’s Drug Review Profile series involve getting FDA to be flexible about what kind of clinical data it requires.